Clinical Data

Efficacy

Tailored dosing based on depth of block for BRIDION (sugammadex)

BRIDION can be used to reverse different levels of rocuronium- and vecuronium-induced neuromuscular blockade (NMB).

Level of NMB with rocuronium or vecuronium

Dose of BRIDION

Example dose of BRIDION for a patient weighing 80 kg

If spontaneous recovery has reached the reappearance of the second twitch (T2) in response to TOF stimulation

2 mg/kg

160 mg (1.6mL)

If spontaneous recovery of the twitch response has reached 1-2 posttetanic counts (PTCs), no twitch responses to TOF

4 mg/kg

320 mg (3.2 mL)

BRIDION dosing should be based on actual body weight.

The recommended dose does not depend on the anesthetic regimen.

Administer BRIDION intravenously as a single bolus injection. The bolus injection may be given over 10 seconds into an existing intravenous line. BRIDION has only been administered as a single bolus injection in clinical trials.

Routine concomitant administration of an anticholinergic agent with BRIDION is not required. Treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.

No dose adjustments of BRIDION required in these special patient populations

Geriatric patients with normal organ function

Patients diagnosed with or who have a history of pulmonary complications

Patients diagnosed with or who have a history of cardiac disease (eg, patients with ischemic heart disease, chronic heart failure, or arrhythmia)

Patients with mild to moderate renal impairment

Convenient single-dose vials

2-mL vial 200 mg BRIDION (sugammadex)

5-mL vial 500 mg BRIDION (sugammadex)

Vials not shown at actual size.

Each single-use vial contains a concentration of 100 mg/mL of sugammadex.

Vials include a peel-off label that can be applied to the syringe.

Drug compatibility

May inject BRIDION into the intravenous line of a running infusion with the following intravenous solutions:

0.9% sodium chloride

5% dextrose

0.45% sodium chloride and 2.5% dextrose

Ringer’s solution

Isolyte P with 5% dextrose

Ringer’s lactate solution

5% dextrose in 0.9% sodium chloride

Ensure the infusion line is adequately flushed (eg, with 0.9% sodium chloride) between administration of BRIDION and other drugs.

Do not mix BRIDION with other products except those listed above.

BRIDION is physically incompatible with verapamil, ondansetron, and ranitidine.

Indication

BRIDION (sugammadex) is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

Selected Safety Information

BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with BRIDION. In a clinical study, anaphylaxis occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The most common hypersensitivity adverse reactions reported were nausea, pruritus and urticaria and showed a dose response relationship, occurring more frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups. Observe patients for an appropriate period of time after administration and take the necessary precautions. Anaphylaxis has also been reported in the post-marketing setting. Clinical features in anaphylaxis reports have included dermatologic symptoms; hypotension often requiring the use of vasopressors; and prolonged hospitalization and/or the use of additional respiratory support until full recovery.

Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of BRIDION. Monitor for hemodynamic changes and treat with anticholinergic agents, such as atropine, if clinically significant bradycardia is observed.

Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Should neuromuscular blockade persist after BRIDION or recur following extubation, take appropriate steps to provide adequate ventilation.

In clinical trials, a small number of patients experienced a delayed or minimal response to BRIDION. Monitor ventilation until recovery occurs.

A minimum waiting time is necessary before re-administration of a steroidal neuromuscular blocking agent after administration of BRIDION.

Re-administration of Rocuronium or Vecuronium after Reversal (up to 4 mg/kg BRIDION)

Minimum Waiting Time

NMBA and Dose to be Administered

5 minutes

1.2 mg/kg rocuronium

4 hours

0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.

Due to the administration of BRIDION, certain drugs, including hormonal contraceptives, could become less effective due to a lowering of the (free) plasma concentrations. Consider re-administration of the other drug, administration of a therapeutic equivalent drug, and/or non-pharmacological interventions as appropriate. If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days. In the case of non-oral hormonal contraceptives, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.

Recurrence of neuromuscular blockade may occur due to displacement of rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation may be required. Stop the administration of the drug which caused displacement, if being administered by infusion.

The use of lower than recommended doses of BRIDION may lead to an increased risk of recurrence of neuromuscular blockade and is not recommended. Also, when drugs which potentiate neuromuscular blockade are used in the post-operative phase, recurrence of neuromuscular blockade is possible.

BRIDION doses of up to 16 mg/kg were associated with increases in activated partial thromboplastin time and prothrombin time/international normalized ratio. Carefully monitor coagulation parameters in patients with known coagulopathies; being treated with therapeutic anticoagulation; receiving thromboprophylaxis drugs other than heparin and low molecular weight heparin; or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg sugammadex.

BRIDION is not recommended for use in patients with severe renal impairment, including those requiring dialysis.

BRIDION has not been studied for reversal following rocuronium or vecuronium administration in the ICU.

Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or steroidal neuromuscular blocking agents other than rocuronium or vecuronium.

The most common adverse reactions (reported in ≥ 10% of patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%, 12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at 38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%, or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at 8%).

BRIDION®

Indication

BRIDION (sugammadex) is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

Selected Safety Information

BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with BRIDION. In a clinical study, anaphylaxis occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The most common hypersensitivity adverse reactions reported were nausea, pruritus and urticaria and showed a dose response relationship, occurring more frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups. Observe patients for an appropriate period of time after administration and take the necessary precautions. Anaphylaxis has also been reported in the post-marketing setting. Clinical features in anaphylaxis reports have included dermatologic symptoms; hypotension often requiring the use of vasopressors; and prolonged hospitalization and/or the use of additional respiratory support until full recovery.

Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of BRIDION. Monitor for hemodynamic changes and treat with anticholinergic agents, such as atropine, if clinically significant bradycardia is observed.

Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Should neuromuscular blockade persist after BRIDION or recur following extubation, take appropriate steps to provide adequate ventilation.

In clinical trials, a small number of patients experienced a delayed or minimal response to BRIDION. Monitor ventilation until recovery occurs.

A minimum waiting time is necessary before re-administration of a steroidal neuromuscular blocking agent after administration of BRIDION.

Re-administration of Rocuronium or Vecuronium after Reversal (up to 4 mg/kg BRIDION)

Minimum Waiting Time

NMBA and Dose to be Administered

5 minutes

1.2 mg/kg rocuronium

4 hours

0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.

Due to the administration of BRIDION, certain drugs, including hormonal contraceptives, could become less effective due to a lowering of the (free) plasma concentrations. Consider re-administration of the other drug, administration of a therapeutic equivalent drug, and/or non-pharmacological interventions as appropriate. If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days. In the case of non-oral hormonal contraceptives, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.

Recurrence of neuromuscular blockade may occur due to displacement of rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation may be required. Stop the administration of the drug which caused displacement, if being administered by infusion.

The use of lower than recommended doses of BRIDION may lead to an increased risk of recurrence of neuromuscular blockade and is not recommended. Also, when drugs which potentiate neuromuscular blockade are used in the post-operative phase, recurrence of neuromuscular blockade is possible.

BRIDION doses of up to 16 mg/kg were associated with increases in activated partial thromboplastin time and prothrombin time/international normalized ratio. Carefully monitor coagulation parameters in patients with known coagulopathies; being treated with therapeutic anticoagulation; receiving thromboprophylaxis drugs other than heparin and low molecular weight heparin; or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg sugammadex.

BRIDION is not recommended for use in patients with severe renal impairment, including those requiring dialysis.

BRIDION has not been studied for reversal following rocuronium or vecuronium administration in the ICU.

Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or steroidal neuromuscular blocking agents other than rocuronium or vecuronium.

The most common adverse reactions (reported in ≥ 10% of patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%, 12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at 38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%, or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at 8%).

Indication

BRIDION (sugammadex) is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

Selected Safety Information

BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with BRIDION. In a clinical study, anaphylaxis occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The most common hypersensitivity adverse reactions reported were nausea, pruritus and urticaria and showed a dose response relationship, occurring more frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups. Observe patients for an appropriate period of time after administration and take the necessary precautions. Anaphylaxis has also been reported in the post-marketing setting. Clinical features in anaphylaxis reports have included dermatologic symptoms; hypotension often requiring the use of vasopressors; and prolonged hospitalization and/or the use of additional respiratory support until full recovery.

Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of BRIDION. Monitor for hemodynamic changes and treat with anticholinergic agents, such as atropine, if clinically significant bradycardia is observed.

Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Should neuromuscular blockade persist after BRIDION or recur following extubation, take appropriate steps to provide adequate ventilation.

In clinical trials, a small number of patients experienced a delayed or minimal response to BRIDION. Monitor ventilation until recovery occurs.

A minimum waiting time is necessary before re-administration of a steroidal neuromuscular blocking agent after administration of BRIDION.

Re-administration of Rocuronium or Vecuronium after Reversal (up to 4 mg/kg BRIDION)

Minimum Waiting Time

NMBA and Dose to be Administered

5 minutes

1.2 mg/kg rocuronium

4 hours

0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.

Due to the administration of BRIDION, certain drugs, including hormonal contraceptives, could become less effective due to a lowering of the (free) plasma concentrations. Consider re-administration of the other drug, administration of a therapeutic equivalent drug, and/or non-pharmacological interventions as appropriate. If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days. In the case of non-oral hormonal contraceptives, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.

Recurrence of neuromuscular blockade may occur due to displacement of rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation may be required. Stop the administration of the drug which caused displacement, if being administered by infusion.

The use of lower than recommended doses of BRIDION may lead to an increased risk of recurrence of neuromuscular blockade and is not recommended. Also, when drugs which potentiate neuromuscular blockade are used in the post-operative phase, recurrence of neuromuscular blockade is possible.

BRIDION doses of up to 16 mg/kg were associated with increases in activated partial thromboplastin time and prothrombin time/international normalized ratio. Carefully monitor coagulation parameters in patients with known coagulopathies; being treated with therapeutic anticoagulation; receiving thromboprophylaxis drugs other than heparin and low molecular weight heparin; or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg sugammadex.

BRIDION is not recommended for use in patients with severe renal impairment, including those requiring dialysis.

BRIDION has not been studied for reversal following rocuronium or vecuronium administration in the ICU.

Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or steroidal neuromuscular blocking agents other than rocuronium or vecuronium.

The most common adverse reactions (reported in ≥ 10% of patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%, 12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at 38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%, or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at 8%).